1 PIONEERING SIGNIFICANT INNOVATIONS IN CLINICAL SOLUTIONS FOR TREATING CANCER AND BRAIN DISORDERS Vol. 16 No. 1 February 2012 Elekta s new inside view PAGE 4 Ultrasound ultra-gentle PAGE 10 Advocacy for all treatment options PAGE 12 Vendor neutral TPS solutions PAGE 18
2 The pioneering spirit continues to define us as we expand our frontiers in radiation oncology. Experience the Elekta Difference. Human Care Makes the Future Possible Vol. 16 No. 1 February 2012 Published by Elekta All letters, comments or suggestions for future articles, requests for reprints and permissions are welcome. Contact Wavelength: Michelle Joiner, Director, Global PR and Brand Management Tel: (time zone: Eastern Standard) Regulatory status of products: This document presents Elekta s product portfolio. Products and indications mentioned may not be approved for certain markets. Art. No Elekta AB (publ). All mentioned trademarks and registered trademarks are the property of the Elekta Group. All rights reserved. No part of this document may be reproduced in any form without written permission from the copyright holder.
3 Contents Brachytherapy Elekta s 4 new inside view Identify simplifying 9 complex workflow Clarity a gentler 10 perspective on soft tissues Lung cancer foundation 12 seeks greater Gamma Knife surgery visibility A new era in Russia 14 Elekta around the world 16 The practicality of neutrality 18 MOSAIQ Evaluate 20 streamlines plan review Satellite clinics are lifelines 22 for cancer patients First MOSAIQ in Japan 23 ClinicalView 24 What makes 26 your center unique? Collaborations & Events 30 Dear friends, Elekta has always been a pioneering company. In recent months, we have taken further steps that promise to carry this spirit forward. One of these is the acquisition of Nucletron, the world leader in brachytherapy. Nucletron s product mix, values and management style fit extremely well with those of Elekta, consolidating our position as a complete provider of radiation oncology. Together we have more than 6,000 customers serving close to one million patients every year. In this issue of Wavelength, you will see how our welcoming of Nucletron into the Elekta family is in complete harmony with our strategy to expand our radiotherapy frontiers for our customers. The article, starting on the next page, explores brachytherapy s place in the modern, versatile cancer clinic. In addition to our brachytherapy news, this issue has an abundance of company news and reports from clinical customers, who just like us are animated by the pioneering spirit and concern for the welfare of patients. Good reading! Tomas Puusepp President and CEO of Elekta AB 3
4 ELEKTA BRACHYTHERAPY SOLUTIONS Elekta s new inside view Elekta reported in September 2011 the completed acquisition of Nucletron, the world leader in brachytherapy. Now, in addition to providing proven solutions employing external beam radiation therapy from the outside-in Elekta also offers a modality that treats cancer from the inside-out. 4 Brachytherapy, or brachy for short, is used extensively to treat gynecological, prostate and breast cancers, in addition to several others. The therapy also boasts lower maintenance and installation costs, shorter treatment times and potentially reduced treatment costs for select indications. Elekta s acquisition positions the integrated company to bring better service to patients, health care providers and health care systems globally. And, as modern cancer care increasingly depends on combinations of different modalities, the joint forces of two key players in external beam and brachy therapy will result in a highly complementary product and technology portfolio. By joining forces with Elekta, Nucletron becomes part of a world-leading provider of radiation therapy for many types of cancers. The promise of brachytherapy Jos Lamers, Executive Vice President of Elekta Brachytherapy Solutions, discusses the promise and potential of brachytherapy in the modern radiation therapy department. Now more than ever, brachytherapy is becoming a critically important modality in cancer management. In brachytherapy, the tumor is irradiated from the inside-out. Over the past few decades, cancer has changed from what was often a fatal disease into a treatable and survivable condition. As a result, today it s more often a matter of the patient s quality of life after treatment, versus a matter of life or death, says Lamers. Several factors have contributed to this important development, including improvements in screening, Jos Lamers Executive Vice President, Elekta Brachytherapy Solutions (previously Nucletron s President and CEO) advanced Technological and scientific developments in recent years have enabled us to treat more tumors with brachytherapy. Regulatory approval differs between markets, please contact the local Elekta representative regarding status for your country. which have enabled cancer detection at a stage at which it can still be treated effectively. Today s imaging techniques also provide much more accurate images of the cancer and the surrounding tissue, which results in better treatment plans. There has also been tremendous progress in cancer treatment itself. Today, a combination of radiation, surgery and chemotherapy depending on the cancer being treated is often used, and the results have been highly successful. Patients make these extremely important choices along with their doctors. Effective multidisciplinary treatment Brachytherapy involves a high radiation dose administered in a short period of time. While this results in a lower total dose, the radiation still kills or reduces the size of the tumor just as effectively. Therapy then only takes a day or a few days. For some prostate cancers, a patient treated with external radiation visits the radiotherapy department five days a week for seven weeks. Brachytherapy takes only one or two days. It s important to note, says Lamers, that brachytherapy isn t always an alternative to external beam radiation. Although as a monotherapy, brachytherapy is suitable for simple, smaller tumors, for more complex tumors, it s often combined with external beam radiotherapy, as well as chemotherapy and/or surgery. There are numerous other examples in which brachytherapy reflects the increasingly multidisciplinary nature of cancer management. With uterine cancer, for example, several treatment methods are used today. First, a hysterectomy,
5 and then when necessary, radiotherapy to prevent recurrence, either external beam or brachytherapy. A combination of external radiation, brachytherapy and chemotherapy often is used in cervical cancer. At an early stage, prostate cancer can be treated with brachytherapy alone. At a later stage, when the tumor has progressed to outside the prostate wall, a certain dose of external radiation is often administered, together with a brachytherapy boost. And, technological and scientific developments in recent years have enabled treatment of more advanced tumors with brachytherapy. New studies and research The development of brachytherapy continues, with extensive research underway and several studies starting. For instance, Canadian research on brachy therapy for rectal cancer indicates that there is far less risk of cancer recurrence after radiation prior to surgery. Research also is being performed to better understand brachytherapy s role before surgical intervention; internal radiation reduces the size of a tumor. It is then easier for the surgeon to remove, which means less damage to the sphincter and leaving smaller wounds to heal. Another study examines the combination of brachytherapy with external radiation in treating cervical cancer at a more advanced stage. The embrace 1 study focuses on mri guided brachytherapy in locally advanced cervical cancer. Today, point-based two-dimensional brachytherapy is most often used for definitive radiotherapy in cervical cancer. However, mri guided 3d brachytherapy is increasingly in use at several centers, and the results so far are very promising. The aim of the embrace protocol is to introduce mri based brachytherapy in a multicenter setting within the frame of a prospective observational study. The portec-2 2 study (a randomized study comparing external beam to brachytherapy in the treatment of endometrial cancer) in The Netherlands has been discussed worldwide and has been used to formulate guidelines. The wellbeing of patients is the primary benefit of brachytherapy, even when the cancer is incurable. A patient with terminal lung cancer who has obstruction in the bronchi finds it increasingly difficult to breathe, explains Lamers. Brachytherapy can alleviate this condition and allows the patient to breathe more easily. As you can see, brachytherapy is very widely applicable. l References: 1) EMBRACE 2) PORTEC-2 (09) /abstract Brachytherapy basics Brachytherapy is a form of radiation therapy in which a radiation source is placed inside or next to the area requiring treatment. It is commonly used as an effective treatment for gynecological cancers, as well as for cancers of the prostate, breast, head and neck, and in other clinical situations in which soft tissue is involved. Because the radiation is almost entirely confined to the tumor area, a key advantage of brachy is that side effects can be minimized after treatment. Another advantage is it can be used alone or in combination with other therapies such as surgery, chemotherapy and external beam radiotherapy (ebrt). The two primary methods of brachytherapy are high-dose rate (hdr) and low-dose rate (ldr) brachytherapy. With hdr, the physician places applicators in or near the tumor. These applicators, or catheters, are connected by transfer tubes to an afterloader, which delivers the radiation source. By contrast, ldr involves permanent placement of seeds that are implanted, most commonly in the prostate. Brachytherapy treatment results have demonstrated that cure rates are either comparable to surgery and ebrt, or are improved when used in combination with these techniques. In addition, brachytherapy is associated with a reduced risk of serious adverse events. facts Four high-dose rate (HDR) components F Applicators: Hollow, non-radioactive applicators are inserted into the body. F Imaging: Used to get a precise picture of the tumor and to verify correct applicator position. F Treatment planning: Software used to plan which dose of radiation is needed and exactly where the radiation sources should be placed in or next to the tumor. F Afterloader: The radioactive sources are stored in the vault of the remote afterloader. The afterloader guides the radiation source to the tumor via the applicators for a specified length of time at specific positions. l 5
6 ELEKTA BRACHYTHERAPY SOLUTIONS Allies in healing Increasing numbers of clinical sites are performing both external beam radiation therapy (ebrt) and brachytherapy, realizing the benefits that can be derived from a more diverse offering of radiation treatment modalities. These advantages extend to patients in improved quality of life and clinical effectiveness (brachytherapy alone or in combination with ebrt), in addition to the ability to receive treatments under one roof. 6 Elekta interviewed clinicians at three clinical sites which perform both ebrt and brachytherapy on the value of brachytherapy in the multidisciplinary radiation oncology department. How do you define modern brachytherapy? Marijnen: Modern brachytherapy is image guided, preferably mri-based. This enables exact target volume definition and minimizes toxicity. Herman: The use of a high dose rate, which enables a shorter course of radiation therapy with potentially better results than conventional low dose rate brachytherapy. We can use brachytherapy as a single treatment in intraoperative cases for example or in a couple of fractions. Endorectal brachytherapy can take four treatments Pötter: A greater use of image guidance combined with advanced delivery technology that harnesses sophisticated computer technology and treatment planning algorithms. It also uses many methods to assess the dose to the target and organs-at-risk. Increasingly, brachytherapy looks at the balance between target coverage and oar dose volume constraints. What is the role of a brachytherapy installation in the radiation therapy department? Marijnen: Given that brachytherapy requires special skills and a certain volume, brachytherapy is preferably centralized in expert centers, depending on the size of the country or region. In this way, these centers can offer the whole range of radio therapy, with state-of-the art external beam treatment and brachytherapy. Pötter: Brachytherapy should be an integral part in any modern, high volume radiotherapy program, because it covers frequently seen indications, particularly prostate cancer, which benefits from highly efficient, focused radiation delivered to a small volume. However, brachytherapy should not be positioned as a competing modality. It depends on the conditions you are given the disease site and patient preferences, among other factors. For instance, brachy for breast cancer is not especially widespread globally, but is increasingly used for partial breast irradiation. In addition, image guided gynecological applications are emerging, due to Level 1 evidence that it seems to be superior to external beam. Herman: To deliver comprehensive, individualized care which will result in the best outcome for patients brachytherapy options should be available. For example, a patient with t4 rectal cancer should get external beam rt and intraoperative brachytherapy to obtain the best chance of local control. If brachy isn t available at a par ticular center, many t4 rectal cancer patients will Prof. C.A.M. Marijnen, m.d., Chair, Department of Radiation Oncology, Leiden University Medical Center (Leiden, The Netherlands) Prof. Richard Pötter, m.d., Professor and Head, Department of Radiotherapy, Medical University of Vienna, General Hospital of Vienna (akh, Vienna, Austria) Regulatory approval differs between markets, please contact the local Elekta representative regarding status for your country.
7 The radiation oncology department can realize gains in productivity, cost-effectiveness and practice marketing. Joseph M. Herman, m.d., Director, Intraoperative Radiation Therapy, Johns Hopkins University (Baltimore, md, usa) Prof. Christian Kirisits, ph.d., Associate Professor Medical Physics, Brachytherapy, Department of Radiotherapy Medical University of Vienna, General Hospital of Vienna (akh, Vienna, Austria) receive external beam rt alone to gy without iort. This is likely to increase local recurrence rates. Utilizing iort following neoadjuvant rt can reduce local recurrence by approximately 50 percent. What are the advantages of brachytherapy for the clinician, the payer and the patient? Marijnen: For the clinician, brachytherapy enables dose delivery with limited additional margins, enabling treatment with minimal toxicity. For the payer although brachy seems more labor intensive the reduced toxicity and the possibility to achieve higher cure rates will be cost-effective in the long run. For select patients, brachytherapy will finally lead to less toxicity and improved long term quality of life compared to external beam treatment. We have already demonstrated this in the portec-2 trial, which randomized ebrt versus vaginal brachytherapy for high intermediate risk endometrial cancer. Herman: Again, to offer truly comprehensive care for oncology patients, especially in locally advanced disease, modern brachytherapy should be an option even if it s used solely in intraoperative cases or as an adjunct. It s important to devise modern clinical trials to integrate and/or evaluate modern brachytherapy techniques to determine the true efficacy of these modalities. Many trials evaluate external beam radiation with various drugs. We need to evaluate the efficacy of combining modern brachytherapy with concurrent targeted and/or chemotherapies as well as radiation protectors. So, while historically it has been brachy therapy. While historically trials have evaluated brachytherapy alone, we have the opportunity to explore novel targeted agents that could potentiate brachytherapy s effects. Payers have viewed brachy favorably and that is reflected by good reimbursement rates. As long as the modality is clinically indicated and likely to improve patient outcome, it is justifiable and needs to be conveyed as such with individual insurance companies. Brachytherapy is attractive for cancer patients because it is delivered over a shorter course. By treating the tumor and/or tumor bed, it delivers a dose of radiation to the surface while limiting dose to normal tissues. This may result in an improved quality of life for some patients. Pötter: Clinicians like brachytherapy because they can escalate the dose in a small volume while limiting the dose to normal, uninvolved tissues. And, after gaining the expertise needed in handling the special applicators, brachy is a rather straightforward procedure, which makes it quite useful. For the payer, the modality is extremely cost-effective because it can yield a local control rate of 90 percent and higher. That means for a single treatment, the probability of having a recurrence is quite low, as are side effects. Of course, there are wide differences in healthcare systems worldwide that will impact on cost-effectiveness. Patients often opt for brachytherapy due to the considerably shorter treatment course typically for many indications it s the difference between one or two treatment sessions versus five days per week for seven to eight weeks. Cervical cancer presents a more >> 7
8 ELEKTA BRACHYTHERAPY SOLUTIONS Allies in healing 8 >> challenging problem, but even then brachy can be more attractive for patients. The standard treatment is five weeks of chemo/radiation therapy, while brachytherapy can last just one to two weeks at a similar total dose and with very few side effects. Where does brachytherapy fit into the radiation oncology armamentarium? Pötter: In contemporary radiotherapy programs, there should be the opportunity and means to deliver a significant dose to a specific target volume. Brachytherapy meets this need in a unique way compared to traditional radiation therapy. If the volume is small from the beginning, such as the prostate, brachy can definitely be considered frontline therapy. Conversely, if there is the likelihood of target shrinkage over the therapy course cervical cancer being a classical example it may be used as a boost. The same factors apply for breast cancer. There is growing use of brachy alone to deliver partial breast irradiation, and the modality is increasingly used for recurrence in the intact breast and as a boost after ebrt. Other more niche, but certainly valid, indications include interstitial applications, such as in anal cancer and head and neck cancer, in addition to treatment of sarcoma and palliative therapy for esophageal cancer. Herman: Generally, when brachy may be indicated for patient care, patients should be evaluated in a multidisciplinary setting to ensure they will obtain the optimal combination of surgery, chemotherapy and radiation, including brachytherapy. So it should be considered as part of the whole approach. Historically, the problem has been that brachy has been sort of an afterthought or available only Patients often opt for brachytherapy due to the considerably shorter treatment course typically for many indications it s the difference between one or two treatment sessions versus five days per week for seven to eight weeks. in certain institutions that offer the treatment. Brachytherapy should be part of the discussion in multidisciplinary tumor boards in the context that it should always be considered in specific patients and earlier on in the treatment process. For intraoperative brachy, there are good data that suggest improved local control. So, any kind of recurrent tumor at this institution is at least considered for brachytherapy. Marijnen: I see a great opportunity for brachytherapy in the area of organ preservation. Whether brachytherapy should be combined with external beam or not depends on tumor type and treatment indication. How do you see brachytherapy evolving in the next five years? Marijnen: The major improvements in brachytherapy will be in image guidance. The possibility of mri compatible applicators enables far better dose delivery, leading to better tumor control and less morbidity. Herman: The combination of brachy with novel targeted therapies that exploit the radiobiological properties that it may offer that may be different from standard fractionated therapies. We re learning that the radiobiology of shorter high dose rates of radiation therapy may be more beneficial in tumors that are generally resistant to standard therapies. Some of the same principles that we re learning with stereotactic radiation therapy can be adapted to high-dose rate brachytherapy. The key benefit is you re moving all the tissues out of the way of the beam. Kirisits: Technologically, it will continue its evolution toward an increasingly image guided, adaptive approach. Various imaging techniques are available ct, magnetic resonance and ultrasound but we have to make them available in a very practical way, so they can be integrated easily into daily clinical practice. We also need tools for online, simple adaptations of treatment plans, similar to how ultrasound is used to image the prostate. Clinicians are doing real-time plans, in which they not only can see the application itself, but also the isodoses while using certain applicators. These technologies become really image guided during insertion of the applicators and possibly even during dose delivery in the future. Pötter: Functional imaging techniques could allow us to fine-tune the dose distribution within the prostate, for example, to focus an even higher dose to certain areas of the gland. We can already focus the dose, but right now we don t exactly know where to put it, which is critical. These same advances could apply to gynecological indications as well. l
9 PRODUCT HIGHLIGHT Identify simplifies complex treatment workflow Highlighted at the 2011 European Society for Therapeutic Radiology and Oncology (estro) and American Society for Radiation Oncology (astro) meetings, Elekta s Identify manages the complexity of the radiotherapy process. Identify is designed to enhance patient safety in the clinic, raise staff confidence in the reliability of patient identification and accessories, and supports best practices of the radiation therapist. Identify employs advanced rfid (radio-frequency identification) technology to ensure the right patient is being treated at the right location and with the correct set up and equipment. Integrated with Elekta s mosaiq Oncology Information System, Identify enables patient queuing, automatic opening of patient charts and treatment tracking at the emr, optimizing workflow. Through this automated process, independent real-time verification of the patient, accessories and their position is performed without impacting the treatment workflow. l Watch a demonstration of Identify at elekta.com/astro Simulation 1 Patient enters CT scanner room 2 Patient selected from MOSAIQ schedule 3 Patient and accessories positioned for treatment (including RFID tags & optical markers) 4 CT scan performed 5 Identify records snapshot of the patient and the positional information of the accessories 6 Data exported to MOSAIQ 9 Treatment 1 Patient enters the treatment room 2 Patient and accessories positioned for treatment 3 Image guidance performed 4 Remote table correction performed 5 Treatment delivery 6 Treatment complete Identify recognizes the patient and verifies their identity matches that of the selected patient & treatment in MOSAIQ Identify visually assists the therapist with the correct positioning of the accessories and verifies the patient setup position is as planned Identify monitors patient position in real-time, and interupts treatment if the patient moves outside a pre-defined tolerance Identify sends a report to MOSAIQ These workflow diagrams show how Identify seamlessly integrates with both simulation and treatment processes, enabling accurate and efficient reproduction of patient set-up. Identify is a work in progress and is not for sale in some markets.
10 CUSTOMER PERSPECTIVE A gentler perspective on soft Fletcher Allen Health Care physicians rely on Clarity ultrasound for patients with breast and prostate cancers. 10 Non-ionizing, patient-friendly ultrasound via Elekta s Clarity system is enhancing the patient experience at Fletcher Allen Health Care (Burlington, vt, usa), and has proven indispensable in its ability to visualize soft tissues in patients undergoing treatment for breast or prostate cancer. Fletcher Allen radiation oncologists Ruth Heimann, m.d., ph.d. and James Wallace, m.d. have been using Clarity for several years to better characterize the lumpectomy cavity and prostate before and during radiation therapy. Clarity helps visualize lumpectomy cavity Since 2007, Dr. Heimann has been using fused Clarity/ct images to depict the dimensions and location of the lumpectomy cavity prior to electron boost treatments. Clarity has helped Dr. Heimann and her colleagues evolve beyond having to infer the lumpectomy cavity s proportions and position using conventional techniques. We had been using superficial skin guidance, she says. We would estimate the location of the cavity by palpating the scar site, and use ultrasound not for localization, but to ascertain the depth of the cavity from the skin surface. We would then set the patient up daily based on surface skin markers over the scar. Subsequently, we learned that the cavity volume and location can change over time. The integration of cone beam ct imaging technology in linear accelerators addresses cavity localization issues to a degree, but at the cost of a small dose of ionizing radiation. Clarity ultrasound was appealing to us not only because this modality easily visualizes the lumpectomy cavity, but also because there is no daily ionizing radiation dose given, Dr. Heimann notes. Many of our patients are younger women and with Clarity we can avoid giving a dose to normal tissues in the affected breast and exposure to the contralateral non-cancerous breast. Fused CT and Clarity images are superior At Fletcher Allen for hundreds of patients over the last four years the only ionizing imaging dose given during the entire treatment course is the single ct simulation scan, which precedes the initial Clarity scan. The ct and Clarity images are fused, providing an image with more anatomical information than what could be provided by the individual modalities. The fused ct/clarity image is truly superior, she says. It gives you a good combination of soft tissue visualization and bony landmarks. Precise localization of the lumpectomy cavity and determination of its exact 3d volume are critical for planning e-boost treatments. Ruth Heimann, m.d., ph.d. James Wallace, m.d. Below: Lumpectomy cavities are typically contoured using only ct only, left, where it can sometimes be hard to distinguish cavity (blue contour) from normal breast tissue. These fluid-filled cavities are well visualized using Clarity. By fusing this information with ct, right, physicians are able to more confidently contour the desired target (yellow contour). Above: The importance of planning the boost closer to the beginning of treatment. Cavities shrink over the whole breast therapy. The different colored contours from Clarity images acquired at different intervals during whole breast therapy show this change. Clarity can be used to track size and position of the target over treatment.
11 tissues We can obtain more accurate coverage of the lumpectomy cavity and ensure that less normal tissue is exposed, Dr. Heimann adds. The Clarity scan also is useful for daily positioning of the patient, to make certain the patient is in the exact position as she was during simulation. In addition, electronic documentation of e-boost treatments are facilitated for the first time by placing the Clarity images in the mosaiq emr. Clarity is well integrated here at Fletcher Allen, she says. While ultrasound is a modality most therapists don t usually encounter, they were easily trained. They really like it. Clearer view of the prostate Clarity soft tissue visualization software is a well- integrated component of Fletcher Allen s prostate radiation therapy workflow. The service treats 10 to 15 patients daily and 60 to 70 new patients annually receive radiation therapy for prostate cancer at Fletcher Allen. Clarity ultrasound was appealing to us not only because this modality easily visualizes the lumpectomy cavity, but also because there is no daily ionizing radiation dose given. Ultrasound/ct fusion with Clarity provides significantly superior prostate visualization than does ct alone, and is a more practical solution than ct/mri fusion, Dr. Wallace says. ct overestimates prostate margins by 20 percent, which makes it difficult to differentiate the prostate from surrounding tissues, he notes. Conversely, if you can get a good acoustic window, ultrasound imaging provides beautiful prostate images, which when fused with the planning ct images give you a comprehensive view of the anatomy. About 20 percent of Fletcher Allen s patients with prostate cancer have had recurrence following prostatectomy. Clarity has also proved valuable in these cases. We use the base of the bladder as our surrogate for the prostate bed and perform a daily Clarity scan, and a weekly cbct scan to ensure we re not seeing any systematic error, Dr. Wallace says. The correlation has been outstanding. Fletcher Allen is also one of a few sites that is evaluating a new Clarity Autoscan functionality, which may enable remote real-time scanning while the treatment beam is on. l Above, upper: ct alone can overestimate the prostate volume. Lower: Fused Clarity and ct helps physicians contour by showing soft tissue detail for target and surrounding anatomy. Clarity positioning for prostatectomy cases using the bladder neck. Green is the reference from Clarity images taken at simulation and red is the current image from treatment. The blue contours are the CT bladder and rectum. fahc clinicians align the inferior bladder wall to achieve daily positioning. 11